Occlusion detection for a fluid infusion device

• US 9,017,307 B2
• Filed: 04/19/2013
• Issued: 04/28/2015
• Est. Priority Date: 12/22/2010
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Kow, Hsiao-Yu S., Bazargan, Afshin, Hanson, Ian B., Vazquez, Pablo, Alderete, Juan M. Jr., Monirabbasi, Salman
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US13/866,231
• Publication Number:
  US 20130237953A1
• Time in Patent Office: 739 Days
• US Class Current: 604/503
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G01F 13/00 Apparatus for measuring by volume and delivering fluids or fluent solid materials, not provided for in the preceding groups
• CPC Class Codes: G01L 1/26 Auxiliary measures taken, or devices used, in connection with the measurement of force, e.g. for preventing influence of transverse components of force, for preventing overload

Abstract

A device for delivering fluid to a user includes a housing, a drive motor assembly in the housing, a force sensor, and an electronics module. The drive motor assembly regulates delivery of fluid by actuating a piston of a fluid reservoir, and the force sensor generates output levels in response to force imparted thereto during, for example, fluid delivery operations. The electronics module processes the output levels of the force sensor to assess the operating health of the force sensor, to check for occlusions in the fluid delivery path, and to monitor the seating status of the fluid reservoir.

Claims

1. A method of detecting occlusions in a fluid path of a fluid infusion device having a drive motor assembly that actuates a piston of a fluid reservoir to deliver fluid from the fluid reservoir, the method comprising:

initiating a fluid delivery action to deliver an amount of fluid from the fluid reservoir;

determining, for each of a plurality of measurement points associated with the fluid delivery action, a respective measurement of a quantity that is indicative of pressure in the fluid path, along with a respective delivered volume measurement relative to a reference volume measurement;

calculating a first slope based upon a current measurement of the quantity, a previous measurement of the quantity, a current delivered volume measurement corresponding to the current measurement of the quantity, and a previous delivered volume measurement corresponding to the previous measurement of the quantity;

calculating a second slope based upon the current measurement of the quantity, an intervening measurement of the quantity that is determined after determining the previous measurement of the quantity, the current delivered volume measurement, and an intervening delivered volume measurement corresponding to the intervening measurement of the quantity; and

indicating whether an occlusion has occurred by using the first slope and the second slope.

2. The method of claim 1, further comprising the step of initiating corrective action for the fluid infusion device when the indicating step determines that the occlusion has occurred.

3. The method of claim 1, wherein:

the quantity is associated with an actuation force of the piston; and

the determining step determines a respective force measurement for each of the plurality of measurement points.

4. The method of claim 1, wherein the indicating step determines that the occlusion has occurred when the first slope is greater than or equal to a first threshold slope value.

5. The method of claim 4, wherein the indicating step determines that the occlusion has occurred when both:

(a) the second slope is greater than or equal to a second threshold slope value; and

(b) the current measurement of the quantity is greater than or equal to a threshold value of the quantity.

6. The method of claim 5, wherein the first threshold slope is greater than the second threshold slope.

7. A method of detecting occlusions in a fluid path of a fluid infusion device having a drive motor assembly that actuates a piston of a fluid reservoir to deliver fluid from the fluid reservoir, the method comprising:

initiating a fluid delivery action to deliver an amount of fluid from the fluid reservoir;

determining, for each of a plurality of measurement points associated with the fluid delivery action, a respective measurement of a quantity that is indicative of pressure in the fluid path, along with a respective delivered volume measurement relative to a reference volume measurement;

comparing a current delivered volume measurement to a predetermined large volume window measurement and a predetermined small volume window measurement;

if the current delivered volume measurement is greater than the predetermined large volume window measurement, calculating a first slope based upon a current measurement of the quantity, a previous measurement of the quantity, the current delivered volume measurement corresponding to the current measurement of the quantity, and a previous delivered volume measurement corresponding to the previous measurement of the quantity;

indicating an occlusion has occurred when the first slope is greater than or equal to a first threshold slope value.

8. The method of claim 7, wherein if the current delivered volume measurement is less than the predetermined large volume window measurement but greater than the predetermined small volume window measurement, the method further comprises:

calculating a second slope based upon the current measurement of the quantity, an intervening measurement of the quantity that is determined after determining the previous measurement of the quantity, the current delivered volume measurement, and an intervening delivered volume measurement corresponding to the intervening measurement of the quantity; and

indicating that an occlusion has occurred when both;

(a) the second slope is greater than or equal to a second threshold slope value; and

(b) the current measurement of the quantity is greater than or equal to a threshold value of the quantity.

9. The method of claim 7, wherein if the current delivered volume measurement is less than the predetermined small volume window measurement, the method further comprises:

determining if additional fluid delivery actions are required to deliver the amount of fluid from the fluid reservoir;

if additional fluid delivery strokes are needed, initiating a fluid delivery action; and

determining if a current force measurement is greater than a gross delivery force limit.

10. The method of claim 7, wherein prior to the determining step, the method further comprises:

determining an initial measurement of force that is indicative of initial pressure in the fluid path; and

indicating that an occlusion has occurred if the initial measurement of force is greater than an initial measurement of force limit.

11. The method of claim 7, further comprising initiating corrective action for the fluid infusion device after indicating that the occlusion has occurred.

12. The method of claim 7, wherein:

the quantity is associated with an actuation force of the piston; and

the determining step determines a respective force measurement for each of the plurality of measurement points.

13. The method of claim 7, wherein if the current delivered volume measurement is greater than the predetermined large volume window measurement, the method further comprises:

if the first slope is less than the first threshold slope value, calculating a second slope based upon the current measurement of the quantity, an intervening measurement of the quantity that is determined after determining the previous measurement of the quantity, the current delivered volume measurement, and an intervening delivered volume measurement corresponding to the intervening measurement of the quantity; and

indicating that an occlusion has occurred based on the second slope.

14. The method of claim 13, wherein the indicating step determines that the occlusion has occurred when both:

(a) the second slope is greater than or equal to a second threshold slope value; and

(b) the current measurement of the quantity is greater than or equal to a threshold value of the quantity.

15. A method of detecting occlusions in a fluid path of a fluid infusion device having a drive motor assembly that actuates a piston of a fluid reservoir to deliver fluid from the fluid reservoir, the method comprising:

initiating a fluid delivery action to deliver an amount of fluid from the fluid reservoir;

determining an initial measurement of force that is indicative of initial pressure in the fluid path;

if the initial measurement of force is less than or equal to an initial measurement of force limit;

determining, for each of a plurality of measurement points associated with the fluid delivery action, a respective measurement of a force that is indicative of an actuation force imparted to a force sensor by the piston, along with a respective delivered volume measurement relative to a reference volume measurement;

calculating a first slope based upon a current measurement of force, a previous measurement of force, a current delivered volume measurement corresponding to the current measurement of force, and a previous delivered volume measurement corresponding to the previous measurement of force;

calculating a second slope based upon the current measurement of force, an intervening measurement of force that is determined after determining the previous measurement of force, the current delivered volume measurement, and an intervening delivered volume measurement corresponding to the intervening measurement of force; and

indicating that an occlusion has occurred based on the initial measurement of force, the first slope and the second slope.

16. The method of claim 15, wherein the indicating step determines that the occlusion has occurred when the initial measurement of force is greater than an initial measurement of force limit.

17. The method of claim 15, wherein the indicating step determines that the occlusion has occurred when the first slope is greater than or equal to a first threshold slope value.

18. The method of claim 15, wherein the indicating step determines that the occlusion has occurred when both:

(a) the second slope is greater than or equal to a second threshold slope value; and

(b) the current measurement of force is greater than or equal to a threshold value of force.

19. The method of claim 15, further comprising initiating corrective action for the fluid infusion device after indicating that the occlusion has occurred.

20. The method of claim 19, wherein initiating corrective action further comprises:

generating an alert or alarm at the fluid infusion device.